FDA clears a Medrobotics Corp. 510(k) for expanding the use of the Flex Robotic System for robot-assisted visualization in general surgical, gynecolog...
To address ongoing critical product shortages, FDA approves shelf life extensions on certain Baxter Healthcare intravenous solutions that are in short...
Federal Register notice: FDA determines for patent extension purposes that the regulatory review period for Ardea Biosciences Zurampic (lesinurad) was...
FDA grants Janssen a priority review for its supplemental BLA to use Darzalex (daratumumab) in combination with bortezomib, melphalan and prednisone f...
FDA sends South Korea-based Daewoong Pharmaceutical a 10-item Form 483 after an 11/2017 inspection found significant GMP violations at the drug substa...
FDA clears a Surmodics 510(k) for its Telemark .014 inch coronary and peripheral support microcatheter, intended for use in complex coronary and perip...
FDA Review posts the Federal Register notices for the week ending 1/19/2018.